Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers-2025/6/5

CVM GFI #287 - Raw Data for Safety and Effectiveness Studies-2025/6/4

Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs Draft -2026/6/4

M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver Draft -2025/5/30

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Final Guidance for Industry and Food and Drug Administration Staff-2025/5/29

Electronic Submission Template for Medical Device Q-Submissions Draft Guidance for Industry and Food and Drug Administration Staff-2025/5/29

Replacing Color Additives in Approved or Marketed Drug Products-2025/5/29

Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry-2025/5/2

Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry-2025/5/2

Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff-2025/3/31